Prosthetic heart valve packaging

ABSTRACT

A packaging assembly for storing a bioprosthetic heart valve is disclosed. The packaging assembly can include a sub-assembly comprising a valve holder configured to hold the bioprosthetic heart valve, and a clip configured to receive a shaft of the valve holder. The clip can comprise a body having an outer periphery and opposing inner edges. The opposing inner edges can define a slot in the body for receiving the shaft of the valve holder. The slot can be open at a first end of the body and extend, along a longitudinal axis of the body, from the first end to a docking aperture. The clip can further comprise a compliance feature in an interference-fit area of the slot adjacent to the docking aperture. The compliance feature can comprise a cutout adjacent to each of the opposing inner edges such that each of the opposing inner edges defines a beam within the interference-fit area.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of International Patent ApplicationNo. PCT/US2020/044701, filed Aug. 3, 2020, which claims the benefit ofU.S. Patent Application No. 62/882415, filed on Aug. 2, 2019, the entiredisclosures all of which are incorporated by reference for all purposes.

TECHNICAL FIELD

This invention relates generally to packaging for prosthetic heartvalves and, more particularly, to a packaging sub-assembly comprising aclip having a compliance feature.

BACKGROUND

Heart valve disease continues to be a significant cause of morbidity andmortality. Currently, the primary treatment of heart valve disease isheart valve replacement. A prosthetic heart valve can be environmentallysensitive and must be packaged to protect the valve from impacts andcontamination during transportation. It is important, therefore, forpackaging to provide a structure that can protect the heart valve, butalso allow the valve to be easily removed without damage orcontamination.

Manufacturers have suspended bioprosthetic heart valves within packagingcontainers for shipping and storage prior to use in the operating room.The valves have been stabilized with various structures, including, forexample, a valve holder and a retainer clip having a radial slot forreceiving a shaft of the valve holder (as shown, for example, in U.S.Pat. No. 9,539,080), and a packaging sleeve that fits closely within ajar and has a clip structure for securing a valve holder (as shown, forexample, in U.S. Pat. Nos. 8,839,957; 9,918,836; and 9,295,539).

Current use of an interference fit between the retainer clip and thevalve holder has had mixed success. For example, some valves have becomedislodged from the retainer clip during shipping simulation, while othervalves have become stuck or difficult to remove from the retainer clip.Adjusting the interference fit is a challenge, as a minuscule change inthe interference feature can significantly affect the force required torelease the valve holder from the retainer clip.

It should be appreciated that there is a need for an improvedheart-valve packaging system that is configured to securely maintain abioprosthetic heart valve within the packaging system, while allowingfor easy removal of the heart valve from the packaging system withoutdamage or contamination. The present invention fulfills this need andprovides further related advantages.

SUMMARY

The present invention is embodied in a packaging assembly for storing abioprosthetic heart valve. In one embodiment, the packaging assemblyincludes a sub-assembly comprising a valve holder configured to hold thebioprosthetic heart valve, and a clip configured to receive a shaft ofthe valve holder. The shaft has a shaft width, and the clip comprises abody having an outer periphery and opposing inner edges. The opposinginner edges define a slot in the body for receiving the shaft of thevalve holder. The slot is open at a first end of the body and extends,along a longitudinal axis of the body, from the first end to a dockingaperture. The clip further comprises a compliance feature in aninterference-fit area of the slot adjacent to the docking aperture. Inone embodiment, a slot width between the opposing inner edges of thebody in the interference-fit area is less than the shaft width. Inanother embodiment, the compliance feature comprises a cutout adjacentto each of the opposing inner edges such that each of the opposing inneredges defines a beam within the interference-fit area.

In one embodiment, the body can be substantially planar. In anotherembodiment, the cutout adjacent to each of the opposing inner edges canbe oblong. In a further embodiment, the slot width can decrease from thefirst end of the body to the interference-fit area. In an additionalembodiment, the clip can comprise a molded polymer. In yet anotherembodiment, the clip can comprise a high-density polyethylene or anacetal resin or a polyoxymethylene, such as DELRIN® (manufactured byDupont).

In one embodiment, the beam defined by each of the opposing inner edgescan be a fixed beam, a cantilevered beam, or a simply-supported beam. Inan additional embodiment, the beam defined by each of the opposing inneredges can have an average beam width from about 0.5 mm to about 2 mm.

In one embodiment, the shaft of the valve holder can have asubstantially circular cross-section. In another embodiment, the valveholder can further comprise a cap coupled to a first end of the shaftand an engagement structure coupled to a second end of the shaft,wherein the engagement structure is configured to removably couple tothe bioprosthetic heart valve. In a further embodiment, the shaft canseparate the cap and the engagement structure. In an additionalembodiment, the engagement structure can comprise a plurality of legs.In yet another embodiment, the plurality of legs can be outwardly anddownwardly angled.

In one embodiment, the packaging assembly can further comprise a storagetray having a stepped ledge surrounding a cavity. In another embodiment,the clip's body can be shaped to rest on the stepped ledge of thestorage tray such that the valve holder's engagement structure issuspended within the cavity of the storage tray when the valve holder isdocked within the clip's docking aperture. In a further embodiment, thepackaging assembly can further comprise a gas-permeable lid coupled toan upper surface of the storage tray.

The present invention is also embodied in a holding assembly comprisinga valve holder configured to hold a bioprosthetic heart valve, and aclip configured to receive a shaft of the valve holder. The shaft has ashaft width, and the clip comprises a body having an outer periphery andopposing inner edges. The opposing inner edges define a slot in the bodyfor receiving the shaft of the valve holder. The slot is open at a firstend of the body and extends, along a longitudinal axis of the body, fromthe first end to a docking aperture. The clip further comprises acompliance feature in an interference-fit area of the slot adjacent tothe docking aperture. In one embodiment, a slot width between theopposing inner edges of the body in the interference-fit area is lessthan the shaft width. In another embodiment, the compliance featurecomprises a first cutout adjacent to one of the opposing inner edgessuch that the one of the opposing inner edges defines a beam within theinterference-fit area.

In one embodiment, the body can be substantially planar. In anotherembodiment, the beam defined by one of the opposing inner edges can be afixed beam, a cantilevered beam, or a simply-supported beam. In afurther embodiment, the compliance feature can further comprise a secondcutout adjacent to another of the opposing inner edges such that each ofthe opposing inner edges defines a beam within the interference-fitarea.

In another separate embodiment, a packaging assembly for storing abioprosthetic heart valve is provided. The packaging assembly cancomprise a valve holder and a clip. The valve holder can be configuredto hold the bioprosthetic heart valve. The valve holder can comprise ashaft having a shaft width. The clip can be configured to receive theshaft of the valve holder. The clip can comprise a body having first andsecond ends and peripheral edges extending between the first and secondends. The clip can further comprise a passageway in the body forreceiving the shaft of the valve holder. The passageway can comprise anopening at a first end of the body, a terminal docking end within thebody and opposing inner edges defining a first slot between the openingand the terminal docking end. The first slot can have a width W₂. Theclip can further comprise a release mechanism. The release mechanism cancomprise holds provided on the peripheral edges of the body and a secondset of one or more slots provided between the holds. The second set ofone or more slots can each have a width W₃, an opening at the second endof the body and a slot end within the body. The holds can be configuredto be compressible towards one another to decrease the width W₃ of eachone of the second set of one or more slots. Decreasing the width W₃ ofeach one of the second set of the one or more slots can increase thewidth W₂ of the first slot to permit insertion and removal of the valveholder to and from the slot end.

In one embodiment, the clip can be made of a resilient material. Theresilient material can be a molded polymer. The molded polymer can be ahigh-density polyethylene or an acetal resin or a polyoxymethylene, suchas DELRIN® (manufactured by Dupont).

In one embodiment, the holds can have a concave surface.

In one embodiment, the release mechanism can comprise two slots. In oneembodiment, a distance d₁ between the openings of the release mechanismslots can be greater than a distance d₂ between the release mechanismslot ends.

In one embodiment, the clip can further comprise a compliance feature inan interference-fit area of the slot that is adjacent to the terminaldocking end. A width of the slot in the interference-fit area can besmaller than the shaft width. In one embodiment, the compliance featurecan comprise a cutout adjacent to each of the opposing inner edges inthe interference-fit area such that each of the opposing inner edgesdefines a beam. In one embodiment, the beam defined by each of theopposing inner edges can be a fixed beam, a cantilevered beam, or asimply-supported beam.

In one embodiment, the packaging assembly can further comprise a storagetray having a stepped ledge surrounding a cavity. The clip's body can beshaped to rest on the stepped ledge of the storage tray such that thevalve holder's engagement structure can be suspended within the cavityof the storage tray when the valve holder is docked within the clip'sdocking aperture. The storage tray can comprise a gas-permeable lidcoupled to an upper surface of the storage tray.

In yet a further embodiment, a packaging assembly for storing abioprosthetic heart valve is provided. The packaging assembly forstoring a bioprosthetic heart valve can comprise a valve holder and aclip. The valve holder can be configured to hold the bioprosthetic heartvalve and can comprise a shaft and a shaft width. The clip can beconfigured to receive a shaft of the valve holder. The clip can comprisea body having first and second ends and peripheral edges extendingbetween the first and second ends. The clip can further comprise apassageway in the body for receiving the shaft of the valve holder,wherein the passageway can comprise an opening at a first end of thebody, opposing inner edges defining a slot and a terminal docking endwithin the body. The clip can further include a flap hingedly coupled tothe body and configured to be actuated between an open position and aclosed position. In the open position, the flap can be hingedlypositioned away from the slot to allow the shaft of the valve holder tofreely slide within the passageway between the opening and the terminaldocking end. In the closed position, the flap covers at least a portionof the slot to secure the valve holder in place when positioned in theterminal docking end.

In one embodiment, one or both of the clip and the flap can be made of aresilient material. The resilient material can be a molded polymer. Themolded polymer can be a high-density polyethylene or an acetal resin ora polyoxymethylene, such as DELRIN® (manufactured by Dupont).

In one embodiment, the flap can be sized and shaped to cover or block aportion of the slot to secure the shaft of the valve holder at theterminal docking end and prevent the shaft from sliding out of theopening when the flap is in the closed position. In one embodiment, theflat does not cover the terminal docking end. In one embodiment, theflap can further comprise a protrusion to allow grasping to open andclose the flap. In one embodiment, the passageway width can be nosmaller than the shaft width.

In one embodiment, the clip can further comprise a stepped ledgedisposed within one or both of the slot and the terminal docking end.The flap can rest on the stepped ledge in the closed position.

In one embodiment, the shaft of the valve holder can be retained withinthe terminal docking end without requiring an interference fit withinthe passageway.

In one embodiment, the packaging assembly can further comprise a storagetray having a stepped ledge surrounding a cavity. The clip's body can beshaped to rest on the stepped ledge of the storage tray such that thevalve holder's engagement structure is suspended within the cavity ofthe storage tray when the valve holder is docked within the clip'sdocking aperture. The storage tray can further comprise a gas-permeablelid coupled to an upper surface of the storage tray.

Each feature or concept outlined above is independent, and can becombined with the other features or concepts outlined above or with anyother feature or concept disclosed in this application. Other featuresand advantages of the invention should become apparent from thefollowing description of the preferred embodiments, taken in conjunctionwith the accompanying drawings, which illustrate, by way of example, theprinciples of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an exploded perspective view of a packaging assembly forstoring a bioprosthetic heart valve, in accordance with one embodiment.

FIG. 2 is a perspective view of a valve holder in accordance with oneembodiment.

FIG. 3A is a top orthogonal view of a clip in accordance with oneembodiment.

FIG. 3B is a bottom orthogonal view of the clip of FIG. 3A.

FIG. 3C is a perspective view of the clip of FIG. 3A.

FIG. 3D illustrates a portion of the clip of FIG. 3A enlarged formagnification purposes.

FIG. 3E illustrates a portion of the view of FIG. 3D enlarged formagnification purposes, and depicts a detailed view of asimply-supported beam defined by one of the opposing inner edges of theclip.

FIG. 3F illustrates an alternative embodiment of the portion of the viewof FIG. 3D enlarged for magnification purposes, and depicts a detailedview of a cantilevered beam defined by one of the opposing inner edgesof the clip.

FIG. 4 illustrates a bioprosthetic heart valve and valve holder beingmoved along a slot in the body of the clip in accordance with oneembodiment.

FIG. 5 is a graph illustrating the relationship between interferenceforce and interference width in a clip having no compliance feature and,in another, a clip having a compliance feature in accordance with oneembodiment.

FIG. 6 illustrates an assembled heart valve holder and clip sub-assemblybeing inserted into a storage tray in accordance with one embodiment.

FIG. 7 illustrates a heart valve holder and clip subassembly placedwithin a cavity of a storage tray, and a gas-permeable lid for sealingover an upper surface of the tray, in accordance with one embodiment.

FIG. 8 is a perspective view of another embodiment of a clip and valveholder that can be used in connection with the storage tray.

FIG. 9 is a top orthogonal view of the clip depicted in FIG. 8 in whichthe holds are compressed together to permit easy insertion or release ofthe valve holder shaft to or from the terminal docking end.

FIG. 10 is a top orthogonal view of the clip depicted in FIG. 8 in whichthe holds are released to secure the valve holder shaft within theterminal docking end.

FIGS. 11A and 11B are perspective views from two sides of a furtherembodiment of a clip and valve holder that can be used in the storagetray.

FIG. 11C is an alternate embodiment of the clip and valve holderdepicted in FIGS. 11A and 11B having a stepped ledge to support theflap.

FIG. 12 is a perspective view of the clip depicted in FIGS. 11A and 11Bshowing the flap in the open position to permit easy insertion orrelease of the valve holder shaft to or from the terminal docking end.

FIG. 13 is a perspective view of the clip depicted in FIGS. 11A and 11Bshowing the flap in the closed position to secure the valve holder shaftwithin the terminal docking end.

FIG. 14 is a perspective view of a further embodiment of the clip andvalve holder that can be used in connection with the storage tray.

FIG. 15 is a top orthogonal view of the clip depicted in FIG. 15.

DETAILED DESCRIPTION

With reference now to FIG. 1 of the illustrative drawings, there isshown a packaging assembly 1000 for storing a bioprosthetic heart valve10. The packaging assembly 1000 can include a sub-assembly 100comprising a valve holder no configured to hold the bioprosthetic heartvalve 10, and a clip 130 configured to receive a shaft 112 of the valveholder 110. As will be discussed in more detail below, the sub-assembly100 holding the bioprosthetic heart valve 10 can be placed into acontainer such as a jar (not shown) or a storage tray 200, and furtherprocessed for storage and shipment.

With reference to FIG. 2, the valve holder no can comprise a cap 118coupled to a first end 114 of the shaft 112 and an engagement structure120 coupled to a second end of the shaft 112. In one embodiment, the cap118 can comprise a bore with internal threads 124, the shaft 112 canhave a shaft width W₁ and a substantially circular-cross-section, andthe engagement structure 120 can be configured to removably couple tothe bioprosthetic heart valve 10. For example, the engagement structure120 illustrated in FIG. 2 comprises a plurality of legs 122 that areoutwardly and downwardly angled. The legs 122 can be arranged to contactand engage cusp regions of the heart valve 10, as is known in the art.Although not shown, one configuration for connecting the legs 122 to theheart valve 10 includes attachment sutures that loop throughsuture-permeable material in the heart valve 10 and tie off on the valveholder 110. During implant, a surgeon can manipulate a handle (notshown) screwed into the threaded bore 124 and advance the heart valve 10into implant position. Once in position, the surgeon can sever theattachment sutures coupling the valve holder 110 to the heart valve 10,and remove the valve holder no and the handle.

In accordance with one exemplary embodiment, a clip that provides aninterference-fit with a valve holder is provided. With reference now toFIGS. 3A-3F, the clip 130 can comprise a substantially planar body 132having an outer periphery 134 and opposing inner edges 136A, 136B. Theopposing inner edges 136A, 136B can define a slot 138 in the body 132for receiving the shaft 112 of the valve holder 110. The slot 138 can beopen at a first end 140 of the body 132 and can extend, along alongitudinal axis l of the body 132, from the first end 140 to a dockingaperture 142.

In one embodiment, the slot 138 can include an interference-fit area 150adjacent to the docking aperture 142. A slot width W₂ between theopposing inner edges 136A, 136B of the body 132 can decrease from thefirst end 140 of the body 132 to the interference-fit area 150. In oneembodiment, the slot width W₂ in the interference-fit area 150 can beless than the valve holder's no shaft width W₁. As such, when the shaft112 of the valve holder no is pushed inward along the slot 138 (asillustrated in FIG. 4), the shaft 112 will push against the opposinginner edges 136A, 136B in the interference-fit area 150 before snappinginto (or out of) the docking aperture 142.

The interference-fit area 150 is provided to maintain the valve holder110 within the docking aperture 142, during processing, storage, andshipment—until the valve holder 110 is deliberately removed by thephysician. The interference-fit area 150 should maintain the valveholder no in the docking aperture 142 during transportation, and alsoallow for the easy removal of the valve holder 110 in the operatingroom. Accordingly, the force required to move the valve holder no pastthe interference-fit area 150 should be from about 3 N to about 13 N.This interference force is set by the interference width, which is thedifference between the shaft width W, and the slot width W₂ in theinterference-fit area 150. The interference width might, for example,have a tolerance range of about ±125 μm. However, adjusting theinterference width has been a challenge as a mere 25 μm to 50 μm changecan significantly affect the force required to release the valve holder110 from the clip 130. As a result, current use of an interference fitbetween the clip 130 and the valve holder 110 has had mixed success. Forexample, some valve holders 110 have become dislodged from the clip 130during shipping simulation, while other valve holders 110 have becomestuck or difficult to remove from the clip 130.

In one embodiment, the interference width can be in the range of about 5μm or more, about 10 μm or more, about 15 μm or more, about 20 μm ormore, about 25 μm or more, about 30 μm or more, about 35 μm or more,about 40 μm or more, about 45 μm or more, about 50 μm or more, about 55μm or more, about 60 μm or more, about 65 μm or more, about 70 μm ormore, about 75 μm or more, about 80 μm or more, about 85 μm or more,about 90 μm or more, about 95 μm or more, about 100 μm or more, about105 μm or more, about 110 μm or more, about 115 μm or more, about 120 μmor more, and about 125 μm or more. The interference width can also be ina range between and including any two of the foregoing values.

With continued reference to FIGS. 3A-3F, the present invention overcomesthe challenges associated with the valve holder no becoming stuck ordifficult to remove from the clip 130 as a result of the interferencefit by incorporating a compliance feature 152 in the interreference-fitarea 150. With particular reference to FIG. 3D, the compliance feature152 can comprise a cutout 154A, 154B adjacent to at least one of theopposing inner edges 136A, 136B such that the at least one of theopposing inner edges 136A, 136B defines a beam 156A, 156B within theinterference-fit area 150. In the example shown, the compliance feature152 includes a cutout 154A, 154B adjacent each of the opposing inneredges 136A, 136B such that each of the opposing inner edges 136A, 136Bdefines a beam 156A, 156B within the interference-fit area 150. Thecompliance feature 152 allows the beams 156A, 156B to deform (asillustrated by the phantom beam in FIGS. 3E and 3F), which reduces theforce needed to push the shaft 112 of the valve holder no past theinterference-fit area 150, and increases the tolerance range of theinterference width for a given range of interference forces.

The shape of the cutout 154A, 154B and the beam 156A, 156B, as well asthe average beam width W₃, will depend on the application and the rangeof acceptable interference forces, as well as on the materials used toform the clip 130 and the valve holder 110. In one embodiment, the clip130 can comprise a molded polymer, such as a high-density polyethyleneor an acetal resin or a polyoxymethylene, such as DELRIN® (manufacturedby Dupont).

In some embodiments, the cutout 154A, 154B can be oblong, and can besymmetrical or asymmetrical. For example, the cutout 154A, 154B can havean elliptical, rectangular, rounded rectangular, or stadium shape. Thebeam 156A, 156B defined by each of the opposing inner edges 136A, 136Bcan be a fixed beam, a simply-supported beam, or a cantilevered beam.FIG. 3E illustrates a cutout 154A having a rounded rectangular-shape,adjacent to the inner edge 136A, such that the inner edge 136A defines asimply-supported beam 156A. FIG. 3F illustrates an alternativeembodiment in which the cutout 154A further includes a portion thatextends through the inner edge 136A to the slot 138 such that the inneredge 136A defines a cantilevered beam. In one embodiment, the beam 156Acan have an average beam width W₃ from about 0.5 mm to about 2 mm.

The graph in FIG. 5 illustrates the impact that a compliance feature 152can have on the relationship between the interference force and theinterference width. As is shown, the slope for a clip having nocompliance feature is steep; and the range Δ1 between a minimuminterference width I_(min1) and a maximum interference width I_(max1)—toproduce a desired range of acceptable forces between F_(Low) andF_(High)—is small. On the other hand, the compliance feature 152 reducesthe slope and increases the range Δ₂ between the minimum interferencewidth I_(min2) and the maximum interference width I_(max2)—to producethe same desired range of acceptable forces between F_(Low) andF_(High).

While the two exemplary curves in FIG. 5 are shown as lines, therelationship between the interference force and the interference widthis not necessarily linear. Nevertheless, a line of best fit can beproduced for a non-linear relationship, and the addition of a compliancefeature 152 to the clip 110 will reduce the slope of this line andbroaden the tolerance of the interference width needed to produceinterference forces within a desired range.

With the bioprosthetic heart valve 10 secured to the valve holder no andwith the valve holder 110 secured to the clip 130, the sub-assembly 100can be placed into a container for further processing, storage, andtransportation. In some embodiments (not shown), the sub-assembly 100can be used with a bioprosthetic heart valve 10 that is stored in apreservative solution, such as glutaraldehyde. For these cases, thesub-assembly 100 can be configured to fit closely within a fluid-tightshipping jar, which is filled with preserving solution and sealed with asuitable lid, as described, for example, by U.S. Pat. No. 9,295,539. Inother embodiments, the sub-assembly 100 can be used with a dehydrated ordry bioprosthetic heart valve 10 that is stored in dry packaging, asdescribed, for example, by U.S. Pat. No. 9,539,080.

For instance, with reference now to FIGS. 6 and 7, the bioprostheticheart valve 10 and the engagement structure 120 of the valve holder 110can be lowered into a cavity 220 of a storage tray 200, and the clip 130can sit on a stepped ledge 210 of the storage tray 200 such that theclip 130 caps the cavity 220 of the storage tray 200. In one embodiment,the clip 130 can engage the storage tray 200 in a non-rotating matter,allowing the valve holder no to be held stationary in the storage tray200 while a user couples a threaded handle to the threaded bore 124 ofthe valve holder 110. The clip 130 is preferably formed to have a shapethat corresponds with the shape of the storage tray 200 (or othercontainer). Thus, while the clip 130 is depicted as an irregularhexagon, it should be understood that the clip 130 can be molded orotherwise formed to have a periphery that is round, square, rectangular,or any shape that is appropriate for a desired container. With thesub-assembly 100 in place within the storage tray 200, a gas-permeablelid 300 having an outer band of adhesive (not shown) can be sealed overthe upper surface 230 of the storage tray 200.

With reference now to FIGS. 8-10, another embodiment of a clip 330 isprovided that can be used with the valve holder 110 and storage tray 200in a manner similar to the one depicted and described in relation toFIGS. 1, 4, 6 and 7. Similar to the embodiment of the clip 130 depictedin FIGS. 1, 4, 6, and 7, the clip 330 can retain the shaft 112 of thevalve holder 110 by way of an interference fit. The clip 330 cancomprise a body 332 having an outer periphery 334 and opposing inneredges 336A, 336B. The body 332 can be substantially planar and theopposing inner edges 336A, 336B can define a passageway 338 in the body332 for receiving the shaft 112 of the valve holder 110. The passageway338 can be open at a first end 340 of the body 332 and can extend alonga longitudinal axis 1 of the body 332 from the first end 340 to aterminal docking end 342. One or both of the terminal docking end 342and the passageway 338 can also comprise a stepped ledge 339 onto whicha first end 114 of the shaft 112 can rest. As depicted in FIG. 2, aportion of the first end 114 of the shaft 112 protrudes radiallyoutwardly of the shaft 112 such that it can rest on top of the steppedledge 339.

In one embodiment, the passageway 338 can include an interference-fitarea 350 adjacent to the terminal docking end 342. The interference-fitarea 350 can be the same or similar to the one described in relation toFIGS. 1, 3, 4, 6, and 7 or can simply be a narrowed area. For example, apassageway width W₂ between the opposing inner edges 336A, 336B of thebody 332 can decrease from the first end 340 of the body 332 to thedinterference-fit area 350. In one embodiment, the passageway width W₂of the interference-fit area 350 can be narrower than the valve holder's110 shaft width W₁. As such, when the shaft 112 of the valve holder 110is pushed inward along the passageway 338 (as illustrated in FIG. 9),the shaft 112 will push against the opposing inner edges 336A, 336B inthe interference-fit area 350 before snapping into (or out of) theterminal docking end 342. In one embodiment, the interference width,which is the difference between the shaft width W₁ and the passagewaywidth W₂ of the interference-fit area 350 can be in the range of about 5μm or more, about 10 μm or more, about 15 μm or more, about 20 μm ormore, about 25 μm or more, about 30 μm or more, about 35 μm or more,about 40 μm or more, about 45 μm or more, about 50 μm or more, about 55μm or more, about 60 μm or more, about 65 μm or more, about 70 μm ormore, about 75 μm or more, about 80 μm or more, about 85 μm or more,about 90 μm or more, about 95 μm or more, about 100 μm or more, about105 μm or more, about 110 μm or more, about 115 μm or more, about 120 μmor more, or about 125 μm or more. The interference width can also be ina range including and within any two of the foregoing values.

The clip 330 can include a release mechanism which can increase thedistance between the opposing inner edges 336A, 336B or increase thepassageway width W₂ of the interference-fit area 350 to allow easyinsertion and removal of the valve holder 110 into and from the terminaldocking end 342. The release mechanism can be effectuated by apinch-to-release mechanism as depicted in FIGS. 9 and 10. Thepinch-to-release mechanism can comprise one or more slots 380 havingopen ends disposed from a second end 341 of the body 332 and extendingsubstantially towards the terminal docking end 342. In the embodimentdepicted in FIGS. 8-10, the first 340 and second 341 ends are opposingedges of the body 332 of the clip 330. The two slots 380 can extend atan angle from the open ends 381 and towards the terminal docking end342. Thus, as depicted in FIGS. 8-10, where two slots are provided, thedistance d₁ between open ends 381 of the slots 380 can be greater thanthe distance d₂ between the slot ends 382.

The one or more slots 380 can have the same width or varying widths.While the embodiment in FIGS. 8-10 depicts a pair of slots as havingsubstantially the same width W₃, it is understood that an embodiment canalso comprise a single slot or two or more slots having the same orvarying widths. The one or more slots 380 can be provided between a pairof holds 390 provided at the peripheral edges 343 of the body 332. Theperipheral edge 343 can extend between the first 340 and second 341 endsof the body 332 in a straight line or in a curved and contoured shape asdepicted in FIGS. 8-10. The holds 390 can be pinched together todecrease the widths W₃ of the one or more slots 390 (see FIG. 9) which,in turn, can increase the passageway width W₂ to facilitate easyinsertion and removal of the valve holder's shaft 112 into and out ofthe terminal docking end 342 with less force. The widths W₃ of the oneor more slots 380 may be decreased more substantially at the open ends380 than at the area near the slot ends 382 when the holds 390 arecompressed together. Once the holds 390 are pinched together, the forcerequired to slidably move the valve holder no from the terminal dockingend 342 and through passageway 338 to remove it from the clip 330 isless than 10 N, less than 9 N, less than 8 N, less than 7 N, less than 6N, less than 5 N, less than 4 N, less than 3 N, less than 2 N, or lessthan 1 N. The one or more slots 380 can provide for a more securefixation of the valve holder 110 and a larger dimensional tolerance.

Again, the interference-fit area 350 is provided to maintain the valveholder 110 within the terminal docking end 342 during processing,storage, and shipment—until the valve holder 110 is deliberately removedby the physician. The interference-fit area 350 should maintain thevalve holder 110 in the terminal docking end 342 during transportation,and also allow for the easy removal of the valve holder no in theoperating theater. The interference-fit area may be provided in a mannerdepicted and described with reference to FIGS. 1-7.

With reference now to FIGS. 14-15, yet a further embodiment of a clip530 is provided that can be used with the valve holder no and storagetray 200 in a manner similar to the ones depicted and described inrelation to FIGS. 1, 6, 7, and 8-10. Similar to the embodiment of theclip 330 depicted in FIGS. 8-10, the clip 530 can retain the shaft 112of the valve holder 110 by way of an interference fit. The clip 530 cancomprise a body 532 having an outer periphery 534 and opposing inneredges 536A, 536B. The body 532 can be substantially planar and theopposing inner edges 536A, 536B can define a passageway 538 in the body532 for receiving the shaft 112 of the valve holder 110. The passageway538 can be open at a first end 540 of the body 532 and can extend alonga longitudinal axis l of the body 532 from the first end 540 to aterminal docking end 542. One or both of the terminal docking end 542and the passageway 538 can also comprise a stepped ledge 539 onto whicha first end 114 of the shaft 112 can rest. As depicted in FIG. 2, aportion of the first end 114 of the shaft 112 protrudes radiallyoutwardly of the shaft 112 such that it can rest on top of the steppedledge 539.

In one embodiment, the passageway 538 can include an interference-fitarea 550 adjacent to the terminal docking end 542. The interference-fitarea 550 can be the same or similar to the one described in relation toFIGS. 1, 3, 4, 6, 7, and 8-10 or can simply be a narrowed area. Forexample, a passageway width W₂ between the opposing inner edges 536A,536B of the body 532 can decrease from the first end 540 of the body 532to the interference-fit area 550. In one embodiment, the passagewaywidth W₂ in the interference-fit area 550 can be narrower than the valveholder's no shaft width W₁. As such, when the shaft 112 of the valveholder 110 is pushed inwardly along the passageway 538 (as illustratedin FIG. 9), the shaft 112 will push against the opposing inner edges536A, 536B in the interference-fit area 550 before snapping into (or outof) the terminal docking end 542. In one embodiment, the interferencewidth, which is the difference between the shaft width W₁ and thepassageway width W₂ of the interference-fit area 550 can be in the rangeof about 5 μm or more, about 10 μm or more, about 15 μm or more, about20 μm or more, about 25 μm or more, about 30 μm or more, about 35 μm ormore, about 40 μm or more, about 45 μm or more, about 50 μm or more,about 55 μm or more, about 60 μm or more, about 65 μm or more, about 70μm or more, about 75 μm or more, about 80 μm or more, about 85 μm ormore, about 90 μm or more, about 95 μm or more, about 100 μm or more,about 105 μm or more, about 110 μm or more, about 115 μm or more, about120 μm or more, or about 125 μm or more. The interference width can alsobe in a range including and within any two of the foregoing values.

The clip 530 can include a release mechanism which can increase thedistance between opposing inner edges 536A, 536B to allow easy insertionand removal of the valve holder no into and from the terminal dockingend 542. The release mechanism can be effectuated by a pinch-to-releasemechanism similar to the one depicted in FIGS. 9 and 10. Similar to theembodiment depicted in FIGS. 9 and 10, the pinch-to-release mechanismcan comprise one or more slots 580 having open ends disposed from asecond end 541 of the body 532 and extending substantially towards theterminal docking end 542. Furthermore, similar to the embodimentdepicted in FIGS. 8-10, the first 540 and second 541 ends are opposingedges of the body 532 of the clip 530. The two slots 580 can extend atan angle from the open ends 581 and towards the terminal docking end542. Thus, similar to the embodiment depicted in FIGS. 8-10, where twoslots are provided, the distance d₁ between open ends 581 of the slots580 can be greater than the distance d₂ between the slot ends 582.

The one or more slots 580 can have the same width or varying widths.While the embodiment in FIGS. 14-15 depicts a pair of slots as havingsubstantially the same width W₃, it is understood that an embodiment canalso comprise a single slot or two or more slots having the same orvarying widths. The one or more slots 58o can be provided between a pairof holds 590 provided on the body 532. The holds 590 can be a protrusionfrom the body 532 that allows a finger grip to compress the holds 590together to decrease the widths W₃ of the one or more slots 590 andincrease the passageway width W₂, which facilitates easy insertion andremoval of the valve holder's shaft 112 into and out of the terminaldocking end 542 with less force in a manner similar to the embodimentdepicted in FIG. 9. Alternatively, the holds 590 can also simply be theperipheral edge 543 that extends between the first 540 and second 541ends. Once the holds 590 are pinched together, the force required toslidably move the valve holder no from the terminal docking end 541 andthrough passageway 538 to remove it from the clip 530 is less than 10 N,less than 9 N, less than 8 N, less than 7 N, less than 6 N, less than 5N, less than 4 N, less than 3 N, less than 2 N, or less than 1 N. Theone or more slots 580 can provide for a more secure fixation of thevalve holder no and a larger dimensional tolerance.

As with the embodiment of the clip depicted in FIGS. 1, 3, 4, 6, and 7,the clip 530 can further include a plurality of openings 560 disposedwithin the body 532 to further decrease the force required to slidablymove the valve holder no from the terminal docking end 542 and throughpassageway 538 to remove it from the clip 530. The plurality of openings560 can be formed in any number of shapes (e.g. circular, oval, ovaline,rectilinear) and can be arranged in a variety of ways. In the embodimentdepicted in FIGS. 1, 3, 4, 6, 7, 14 and 15, the plurality of openings isarranged around the terminal docking end 542. In alternativeembodiments, the plurality of openings 56o can be arranged on one orboth sides of the terminal docking end 542.

Again, the interference-fit area 550 is provided to maintain the valveholder 110 within the terminal docking end 542 during processing,storage, and shipment-until the valve holder no is deliberately removedby the physician. The interference-fit area 550 should maintain thevalve holder no in the terminal docking end 542 during transportation,and also allow for the easy removal of the valve holder no in theoperating theater. The interference-fit area may be provided in a mannerdepicted and described with reference to FIGS. 1-7 and 8-10.

In accordance with another exemplary embodiment, a clip that can retainor secure a valve holder without requiring an interference fit isprovided. With reference now to FIGS. 11-13, the clip 43o can comprise abody 432 having an outer periphery 434 and opposing inner edges 436A,436B. The body 432 can be substantially planar and the opposing inneredges 436A, 436B can define a passageway 438 in the body 432 forreceiving the shaft 112 of the valve holder 110. The passageway 438 canbe open at a first end 440 of the body 432 and can extend along alongitudinal axis l of the body 432 from the first end 440 to a terminaldocking end 442. One or both of the terminal docking end 442 and thepassageway 438 can optionally also comprise a stepped ledge 439, asdepicted in FIG. 11C, onto which a first end 114 of the shaft 112 canrest. As depicted in FIG. 2, a portion of the first end 114 of the shaft112 protrudes radially outwardly of the shaft 112.

The clip 430 can further comprise a flap 450 that is coupled to the body432. The flap 450 can be actuated between an open position (FIGS. 11A,11B, 11C and 12) and a closed position (FIG. 13) via a hinge 452. In theopen position depicted in FIGS. 11A, 11B, 11C and 12, the shaft 112 ofthe valve holder no can freely slide in the passageway 438 and bepositioned in the terminal docking end 442 of the body 432. Oncepositioned at the terminal docking end 442, the flap 450 can be actuatedin the closed position, as depicted in FIG. 13 to secure the valveholder within the clip 430.

The flap 450 can be sized and shaped to cover or block at least aportion of the passageway 438 so as to secure the shaft 112 of the valveholder no at the terminal docking end 442 and prevent the shaft 112 fromsliding out of the terminal docking end 442. In accordance with oneaspect of the embodiment, the flap 450 can be sized to rest on top ofthe stepped ledge 439 shown in FIG. 11C to prevent it from over rotatingor falling below the body 432. As depicted in the exemplary embodimentin FIGS. 11-13, the flap 450 can be shaped to include a stepped-inportion 460 covering a portion of the passageway 438 and a stepped-outportion 462 that conforms to at least a portion of the outer periphery434. While the hinge depicted in FIGS. 11-13 is a living hinge 452, itis understood that the flap 450 can be coupled to the body 432 in anyother way that permits the flap 450 to actuate between the open (FIGS.11A, 11B and 12) and closed (FIG. 13) positions. The flap 450 canfurther comprise a protrusion 454 to allow grasping to open and closethe flap 450.

In accordance with one aspect of this embodiment, the shaft 112 of thevalve holder 110 can be retained within the terminal docking end withoutrequiring an interference fit. In other words, the widths of either orboth of the terminal docking end 442 and the passageway 438 need not beless than the valve holder's 100 shaft width W₁. In one embodiment, thewidths of one or both of the passageway 438 or terminal docking end 442is roughly equal to or slightly greater than the width of the shaft 112of the valve holder 110. As such, minimal to no force would be requiredmove the valve holder 110 through the passageway 438 and into or out ofthe terminal docking end 442. The force required to move the valveholder no through the passageway 438 and into the terminal docking end442 can be 5 N or less, 4 N or less, 3 N or less, 2 N or less, or 1 N orless.

It should be appreciated from the foregoing description that the presentinvention provides an improved packaging assembly that provides aninterference force within a desired range over a larger range ofinterference widths, thereby securely maintaining a bioprosthetic heartvalve within the packaging system, while also allowing easy removal ofthe heart valve from the packaging system without damage orcontamination.

Specific methods, devices, and materials are described, although anymethods and materials similar or equivalent to those described can beused in the practice or testing of the present embodiment. Unlessdefined otherwise, all technical and scientific terms used herein havethe same meanings as commonly understood by one of ordinary skill in theart to which this embodiment belongs.

The terms “a,” “an,” and “at least one” encompass one or more of thespecified element. That is, if two of a particular element are present,one of these elements is also present and thus “an” element is present.The terms “a plurality of” and “plural” mean two or more of thespecified element. The term “or” used between the last two of a list ofelements means any one or more of the listed elements. For example, thephrase “A, B, or C” means “A, B, and/or C,” which means “A,” “B,” “C,”“A and B,” “A and C,” “B and C,” or “A, B, and C.” The term “coupled”generally means physically coupled or linked and does not exclude thepresence of intermediate elements between the coupled items absentspecific contrary language.

Without further elaboration, it is believed that one skilled in the art,using the proceeding description, can make and use the present inventionto the fullest extent. The invention has been described in detail withreference only to the presently preferred embodiments. Persons skilledin the art will appreciate that various modifications can be madewithout departing from the invention. Accordingly, the invention isdefined only by the following claims.

What is claimed is:
 1. A packaging assembly for storing a bioprostheticheart valve, the packaging assembly comprising: a sub-assemblycomprising a valve holder configured to hold the bioprosthetic heartvalve, and a clip configured to receive a shaft of the valve holder, theshaft having a shaft width, wherein the clip comprises: a body having anouter periphery and opposing inner edges, the opposing inner edgesdefining a slot in the body for receiving the shaft of the valve holder,wherein the slot is open at a first end of the body and extends, along alongitudinal axis of the body, from the first end to a docking aperture;and a compliance feature in an interference-fit area of the slotadjacent to the docking aperture; wherein a slot width between theopposing inner edges of the body in the interference-fit area is lessthan the shaft width, and wherein the compliance feature comprises acutout adjacent to each of the opposing inner edges such that each ofthe opposing inner edges defines a beam within the interference-fitarea.
 2. The packaging assembly of claim 1, wherein the body issubstantially planar.
 3. The packaging assembly of claim 1, wherein thebeam defined by each of the opposing inner edges is a fixed beam, acantilevered beam, or a simply-supported beam.
 4. The packaging assemblyof claim 1, wherein the cutout adjacent to each of the opposing inneredges is oblong.
 5. The packaging assembly of claim 1, wherein the beamdefined by each of the opposing inner edges has an average beam widthfrom about 0.5 mm to about 2 mm.
 6. The packaging assembly of claim 1,wherein the slot width decreases from the first end of the body to theinterference-fit area.
 7. The packaging assembly of claim 1, wherein theclip comprises a molded polymer.
 8. The packaging assembly of claim 1,wherein the clip comprises a high-density polyethylene or an acetalresin.
 9. The packaging assembly of claim 1, wherein the valve holderfurther comprises a cap coupled to a first end of the shaft and anengagement structure coupled to a second end of the shaft, wherein theengagement structure is configured to removably couple to thebioprosthetic heart valve.
 10. The packaging assembly of claim 9,wherein the shaft separates the cap and the engagement structure. 11.The packaging assembly of claim 9, wherein the engagement structurecomprises a plurality of legs.
 12. The packaging assembly of claim 11,wherein the plurality of legs are outwardly and downwardly angled. 13.The packaging assembly of claim 1, further comprising a storage trayhaving a stepped ledge surrounding a cavity.
 14. The packaging assemblyof claim 13, wherein the clip's body is shaped to rest on the steppedledge of the storage tray such that the valve holder's engagementstructure is suspended within the cavity of the storage tray when thevalve holder is docked within the clip's docking aperture.
 15. Thepackaging assembly of claim 13, further comprising a gas-permeable lidcoupled to an upper surface of the storage tray.